Research Professionals - CRO Post Clinical Study Activities
The Research Professionals CRO Post Clinical Study Service Advantage
Regulatory Submission Experience & Knowledge Leaders
When subjects have completed their study, the work doesn't end there for RP-CRO. Our comprehensive Post-Trial Activities offer numerous advantages to our sponsor customers including:
- Robust clinical study statistical analysis
- Technically sound medical writing services
- Regulatory submissions based on applied knowledge and data
Research Professionals - CRO Post Clinical Study Activities
Managing a clinical study doesn't end when the subjects complete their participation. Every clinical trial requires a host of post-study activities that include consolidation and analysis of trial data for use in regulatory filings or registrations. RP-CRO prioritizes post-clinical study activities so that the sponsor can understand their trial's results and efficiently submit the required study submission documents to the applicable regulatory authorities. Our dedicated staff apply years of clinical study experience to the preparation of every customer regulatory submission, ensuring that all regulatory submissions are complete, and of the highest quality. Regulatory submission management is a core focus at Research Professionals as it represents the critical decision point for regulators in the advancement of customer drug products and medical devices.
Clinical Statistical Data Analysis
Clinical statistical data analysis is an integral part of our post study services. We use powerful data analysis techniques that enable sponsors to draw meaningful conclusions from their clinical study data. Every stage of statistical analysis involves using a set of data cleaning and validation procedures to ensure completeness and validity. Quality control is applied throughout the data handling process, with the data error rate estimated and recorded in the data management master file. Clinical study statistical data management plans help to define optimized data entry and processing approaches so that findings and corrective actions can be documented. A complete statistical analysis is required including the performance of at least one quality assessment before the study database is locked. Our statistical data manager also verifies that all clinical subject visits and assessments are completed and documented through the final cleaning, reconciliation, and verification steps before the database is finally locked. The locked clinical study database remains in our system for at least three months before it is safely and securely archived.
Medical Writing Services
Research Professionals CRO produces a Clinical Study Report (CSR) for every clinical study, which describes the trial data and outcomes observed in the investigation. Our medical writers interpret each study's results against its clinical endpoints or hypotheses and put them into the correct context relative to the clinical statistical analysis. With a strong understanding of the regulatory authority's expectations, Research Professional's experienced medical writing staff create all required study reporting and publish clinical evidence in regulator ready formats. Our medical writing team clearly communicates your clinical study results, so regulators have an effective data driven document on which to base their approvals.
Regulatory Approval and Registration
Research Professionals CRO always strives to maintain the most up-to-date knowledge of applicable regulatory requirements and guidelines so that it can compliantly manage and document sponsor clinical studies from start to finish. The result is clinical study reports in regulator ready formats ideal for inclusion in the submission package. Part of this regulatory knowledge includes maintaining open communications with various regulatory bodies so that negotiations are smooth and well-informed when required. In addition to comprehensive clinical study data management and submission services, RP-CRO also supports post-trial regulatory inspections. We work with our sponsors every step of the way, to support their clinical trials and medical device studies to completion.
- Clinical study statistical data analysis
- Regulatory data preparation reporting
- Submission packages for regulatory authorities and ethics committees
- Harmonize clinical study documentation with local regulatory requirements
- Planning, supporting, and overseeing clinical regulatory inspections
